Business Wire

Ferring Receives EU Approval for REKOVELLE® (follitropin delta)

Del

Ferring Pharmaceuticals announced today that the European Commission (EC) has granted marketing authorisation for REKOVELLE® (follitropin delta), a human recombinant follicle stimulating hormone (human rFSH), for use in controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART), such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.1

REKOVELLE® is the first rFSH to be derived from a human cell line and is the first rFSH treatment to be administered with an individualised dosing regimen.1-5 REKOVELLE®’s individualised dosing regimen is based on a woman’s serum anti-Müllerian hormone (AMH) level and her body weight. With these parameters, a specific daily dose of REKOVELLE® is determined for each patient from the start of the ART cycle.1-4,6,7 AMH has surfaced as one of the most reliable biomarkers for assessing ovarian reserve. It can help predict a woman’s ovarian response to gonadotrophin stimulation and can also help guide the dosing of fertility treatments.8,9 AMH will be measured by a companion diagnostic, the Elecsys® AMH Plus immunoassay from F. Hoffmann-La Roche Ltd (Roche).6,7

The EC approval of REKOVELLE® is based on a comprehensive clinical data package, including results from the Phase 3 ESTHER trials (Evidence-based Stimulation Trial with Human rFSH in Europe and Rest of World).2-4 Results of the ESTHER-1 trial were accepted for publication in Fertility & Sterility (article in press and available early online). The data shows that individualised treatment with REKOVELLE® (follitropin delta), as compared to treatment with conventional rFSH (follitropin alfa), had similar results for the co-primary endpoints of ongoing pregnancy rates and ongoing implantation rates. Patients receiving REKOVELLE® also reached the optimum oocyte yield (8–14 oocytes) more often than those receiving conventional rFSH treatment, with fewer clinically-relevant instances of poor and excessive ovarian response. In addition, ovarian hyperstimulation syndrome (OHSS) and/or OHSS preventive interventions occurred less frequently (p<0.05) in women receiving REKOVELLE® than women receiving conventional rFSH treatment.4

“REKOVELLE®’s individualised dosing regimen offers physicians a new method to deliver a consistent, evidence-based approach to personalising treatment for their patients, based on AMH, a highly predictive biomarker,” commented Professor Anders Nyboe Andersen, Principal Investigator of the ESTHER trials. “Using validated protocols for individualisation could help physicians facilitate the best possible outcomes for their patients by ensuring efficacy is maintained while also reducing complications during treatment.”

REKOVELLE® is an integral part of Ferring’s commitment to translating the practice of personalised medicine into reproductive health and fertility. “Ferring has a long-standing commitment to scientific advancement in reproductive health,” said Michel Pettigrew, President of the Executive Board and COO at Ferring Pharmaceuticals. “As a research-driven company, we believe that by focusing on innovative and personalised approaches, we can continue to lead the way in fertility treatments and help women to plan their futures as mothers.”

- ENDS -

About REKOVELLE ® (follitropin delta)

Follitropin delta (also known as FE 999049) is the first recombinant follicle stimulating hormone (rFSH) derived from a human cell line (PER.C6® cell line).1-4,5,10 It has been developed for individualised dosing based on a woman’s serum anti-Müllerian hormone (AMH) level, as determined by a companion diagnostic, the Elecsys® AMH Plus immunoassay from Roche,4,6,7 and her body weight. Follitropin delta is structurally and biochemically distinct from other existing recombinant FSH treatments.1-4,5,10

About the ESTHER trials

The ESTHER trials (Evidence-based Stimulation Trial with Human rFSH in Europe and Rest of World) were randomised, assessor-blind, controlled, multicentre Phase 3 trials involving patients in 11 countries, and over 2,000 cycles of controlled ovarian stimulation.2-4

About Ferring Pharmaceuticals

Headquartered in Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group, active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopaedics. Ferring has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries. To learn more about Ferring or its products please visit www.ferring.com.

About the Elecsys ® AMH Plus immunoassay from Roche

The Elecsys® AMH Plus immunoassay from Roche has been shown to provide a precise, reliable and robust measurement of AMH levels.6,7,11-14 This fully automated Elecsys® AMH Plus immunoassay, run on the cobas ® e systems and the Elecsys® immunoassay analysers, determines AMH levels in 18 minutes, making it appropriate for routine clinical use. The Elecsys® AMH Plus immunoassay is intended to be used for assessment of ovarian reserve, prediction of response to controlled ovarian stimulation (COS) and establishment of the individual daily dose of Ferring follitropin delta in combination with body weight in COS for the development of multiple follicles in women undergoing an assisted reproductive technology programme.6,7,11-14

References

1. REKOVELLE® Summary of Product Characteristics (SmPC) – Available upon request.

2. Nyboe Andersen A et al. Efficacy and safety of follitropin delta in an individualised dosing regimen: A randomised, assessor-blind, controlled phase 3 trial in IVF/ICSI patients (ESTHER-1). Human Reproduction 2016; 31: 324

3. Buur Rasmussen A et al. Low immunogenicity potential of follitropin delta, a recombinant FSH preparation produced from a human cell line: Results from phase 3 trials (ESTHER-1 and ESTHER-2). Human Reproduction 2016; 31: 385

4. Nyboe Andersen A et al. Individualized versus conventional ovarian stimulation for in vitro fertilization: a multicenter, randomized, controlled, assessor-blinded, phase 3 noninferiority trial. Fertil Steril. In press, available early online. doi.org/10.1016/j.fertnstert.2016.10.033

5. Arce J-C, Nyboe Andersen A, Fernandez Sanchez M, et al. Ovarian response to recombinant human follicle-stimulating hormone: a randomized, antimullerian hormone–stratified, dose–response trial in women undergoing in vitro fertilization/intracytoplasmic sperm injection. Fertil Steril. 2014 Dec;102(6):1633–40.

6. Deeks ED. Elecsys® AMH assay: a review in anti-Müllerian hormone quantification and assessment of ovarian reserve. Mol Diagn Ther 2015; 19: 245-249.

7. Roche Diagnostics. Elecsys® AMH (anti-Mullerian hormone): Method sheet. 2015. https://pim-eservices.roche.com. Last accessed Novemober 2016.

8. Nelson SM et al. Anti-Müllerian hormone-based approach to controlled ovarian stimulation for assisted conception. Hum Reprod. 2009 Apr;24(4):867–75.

9. Fleming R, Broekmans F, Calhaz-Jorge C, et al. Can anti-Mullerian hormone concentrations be used to determine gonadotropin dose and treatment protocol for ovarian stimulation? Reproductive BioMedicine Online 2013;26:431–439.

10. Olsson H, Sandström R, Grundemar L. Different pharmacokinetic and pharmacodynamic properties of recombinant follicle-stimulating hormone (rFSH) derived from a human cell line compared with rFSH from a non-human cell line. J Clin Pharmacol 2014; 54(11):1299–307.

11. Gassner D, Jung R. First fully automated immunoassay for anti-Müllerian hormone. Clin Chem Lab Med. 2014;52(8):1143-52.

12. Anderson RA, Anckaert E, Bosch E, et al. Prospective study into the value of the automated Elecsys antimüllerian hormone assay for the assessment of the ovarian growing follicle pool. Fertil Steril. 2015;103(4):1074–80.e4.

13. Nelson SM, Pastuszek E, Kloss G, et al. Two new automated, compared with two enzyme-linked immunosorbent antimüllerian hormone assays. Fertil Steril. 2015 Oct;104(4):1016-1021.e6.

14. Hyldgaard J, Bor P, Ingerslev HJ, et al. Comparison of two different methods for measuring anti-mullerian hormone in a clinical series. Reprod Biol Endocrinol. 2015 Sep 22;13(1):107.

Contact information

Ferring Pharmaceuticals
Lindsey Rodger
Tel. +41 (0) 58 451 40 23
lindsey.rodger@ferring.com
or
Marion Lindsay
Tel. +41 58 301 04 15
marion.lindsay@ferring.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

AGCO Announces a New Data Connection with The Climate Corporation’s Climate FieldViewTM Digital Agriculture Platform19.10.2017 14:30Pressemelding

AGCO Corporation (NYSE:AGCO), a world-leading manufacturer and distributor of agricultural equipment, announced today a new digital partnership with The Climate Corporation, a subsidiary of Monsanto Company (NYSE:MON), that will provide AGCO customers the option to connect with The Climate Corporation’s Climate FieldView™ platform. AGCO’s partnership with The Climate Corporation is a product of Fuse and its open approach to agriculture, which focuses on helping customers optimize their farms through seamless technology integration and connectivity. “AGCO is excited to work with The Climate Corporation to give our customers yet another choice for Precision Ag solutions,” says Chris Rhodes, director Fuse Business Development. “The Climate FieldView platform is the world’s most broadly connected and adopted farm insight and visualization platform, and AGCO is pleased to be creating a tigh

Arrive Safely: Head to Tirendo and Equip Yourself Properly for Your First Winter19.10.2017 14:25Pressemelding

The days are getting shorter, and the thermometer is dropping. Especially for new drivers looking forward to their first winter behind the wheel, the sudden onset of snowy and icy roads can be a real challenge. Even more important, therefore, to make sure that you have the appropriate tyres for wintry driving conditions. Tirendo shares some tips on what this involves. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171019005888/en/ Head to Tirendo and equip yourself properly for your first winter - Photo source: ENZO In winter weather above all, the correct tread depth is crucial for safe driving. The legal minimum throughout Europe is 1.6 mm, however experts recommend at least 4 mm in snowy and icy conditions to ensure sufficient grip. To measure your tyre’s tread depth, simply take a two euro coin:

EURid Reveals the Nominees for The 2017 .eu Web Awards19.10.2017 13:48Pressemelding

EURid, the .eu and .ею registry, has released the nominees for its .eu Web Awards. The .eu Web Awards is an online competition, launched in 2014, where .eu and .ею websites can be nominated for a chance to win a prestigious award to be presented at a stunning ceremony in Brussels. “As with every iteration of the .eu Web Awards, we are so pleased and humbled to award our domain name holders’ online efforts. We are so grateful to have them in our community and want to show them the support they deserve”, commented Giovanni Seppia, EURid’s External Relations Manager. EURid is pleased to unveil this year’s final nominees, which represent the vast diversity and creativity that embodies Europe: The Leaders An established national business that is currently in operation and possesses multiple years of industry experience.

Andersen Tax Launches in Canada19.10.2017 13:30Pressemelding

Andersen Global is proud to announce the launch of the Andersen name in Canada as SdM Chartered Professional Accountants Inc. formally adopts the name Andersen Tax. SdM, a tax firm based in Montreal, Quebec, became a collaborating firm of Andersen Global in June of 2016 and has now formally joined the organization as a member firm under the name Andersen Tax. “We have been working with Simon and the team in Montreal for several years now, and I’m confident that together we will continue finding the best solutions for our clients,” said Global Chairman and CEO of Andersen Tax LLC, Mark Vorsatz. “Our shared name demonstrates the like-mindedness of our partners and the adoption of the Andersen name in Canada further strengthens our growing footprint in the region.” As Andersen Tax, the Canadian team will continue to provide tax, advisory and international tax services with an e

UL Joins Sustainable Apparel Coalition19.10.2017 12:00Pressemelding

UL announces that it has joined the Sustainable Apparel Coalition (SAC) and will use the group’s sustainability measurement tool, the Higg Index, to drive environmental and social responsibility throughout its supply chain. With its membership in the SAC, UL joins more than 200 global brands, retailers and manufacturers, as well as government, non-profit environmental organizations, and academic institutions, which are collectively committed to improving supply chain sustainability in the apparel, footwear and textile industries. UL partners with clients to support them with every aspect of sustainability and supply chain management, including developing a proactive stance and demonstrating ‘green’ and sustainable credentials, assist in gaining better visibility into supply chain issues and mitigate risk and implementing customized and comprehensive Environmental Mana

Phase III Efficacy and Safety Data for Oral Ozanimod in Relapsing Multiple Sclerosis to Be Presented at MSParis2017 – 7th Joint ECTRIMS – ACTRIMS Meeting19.10.2017 11:30Pressemelding

Celgene Corporation (NASDAQ:CELG) today announced that new data on the efficacy and safety of ozanimod, a novel, oral, selective, sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator, in relapsing multiple sclerosis (RMS) were accepted for the MSParis2017 – 7th Joint ECTRIMS – ACTRIMS Meeting, which is being held in Paris, October 25-28, 2017. “Our strong presence at this year’s meeting and the breadth of data being presented on ozanimod highlight our commitment to bringing forth ozanimod as a potential novel, oral therapeutic option for people with multiple sclerosis,” said Terrie Curran, President, Celgene Inflammation and Immunology. Full results from the phase III SUNBEAM™ and RADIANCE™ Part B studies evaluating two doses of oral ozanimod compared with Avonex® (interferon beta-1a) (IFN) in people with RMS will be presented as an oral and a late-break

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom